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Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

NCT ID: NCT01374906

Last Updated: 2018-05-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-04

Study Completion Date

2016-12-21

Brief Summary

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This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

Detailed Description

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Conditions

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Cushing's Disease

Keywords

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SOM230 Cushing's Disease Mean Urinary Free Cortisol Pasireotide Pasireotide LAR Pasireotide long-acting release secondary hypercortisolism secondary hypercorticism Itsenko-Cushing disease increased secretion of adrenocorticotropic hormone (ACTH) hyperpituitarism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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10 mg LAR dose

Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms.

Group Type EXPERIMENTAL

pasireotide LAR

Intervention Type DRUG

Pasireotide long-acting was administered as an intra-muscular depot intragluteal injection once every 28 days (±2 days). Patients were administered pasireotide long-acting 10 mg or 30 mg for four months, followed by either continuation of the starting dose, or dose up-titration (if mUFC was still \>1.5xULN unless titration was precluded by safety reasons).

SOM230 LAR 10 mg

Intervention Type DRUG

starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.

30 mg LAR dose

Randomization was stratified based on Screening mUFC to ensure balanced distribution of disease severity in the two dose arms.

Group Type EXPERIMENTAL

pasireotide LAR

Intervention Type DRUG

Pasireotide long-acting was administered as an intra-muscular depot intragluteal injection once every 28 days (±2 days). Patients were administered pasireotide long-acting 10 mg or 30 mg for four months, followed by either continuation of the starting dose, or dose up-titration (if mUFC was still \>1.5xULN unless titration was precluded by safety reasons).

SOM230 LAR 30 mg

Intervention Type DRUG

starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose.

Interventions

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pasireotide LAR

Pasireotide long-acting was administered as an intra-muscular depot intragluteal injection once every 28 days (±2 days). Patients were administered pasireotide long-acting 10 mg or 30 mg for four months, followed by either continuation of the starting dose, or dose up-titration (if mUFC was still \>1.5xULN unless titration was precluded by safety reasons).

Intervention Type DRUG

SOM230 LAR 30 mg

starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose.

Intervention Type DRUG

SOM230 LAR 10 mg

starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.

Intervention Type DRUG

Other Intervention Names

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SOM230

Eligibility Criteria

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Inclusion Criteria

* Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)
* For patients on medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed

* Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week
* Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and PPARγ agonists (rosiglitazone or pioglitazone): 4 weeks
* Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks
* Octreotide (immediate release formulation): 1 week

Exclusion Criteria

* Patients who are considered candidates for surgical treatment at the time of study entry
* Patients who have received pituitary irradiation within the last ten years prior to visit 1
* Patients who have had any previous pasireotide treatment
* Patients who have been treated with mitotane during the last 6 months prior to Visit 1
* Diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by HbA1c \>8%
* Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF \>470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval
* Female patients who are pregnant or lactating, or are of childbearing potential (defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control. Sexually active males must use a condom during intercourse while taking the drug and for 2 months after the last dose of study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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ClinTriCo

Phoenix, Arizona, United States

Site Status

University of California at Los Angeles UCLA Tiverton

Los Angeles, California, United States

Site Status

Harbor-UCLA Medical Center LA Biomed

Torrance, California, United States

Site Status

Emory University School of Medicine/Winship Cancer Institute G2304 - C2301

Atlanta, Georgia, United States

Site Status

Pituitary Center, Division of Endocrinology SC

Baltimore, Maryland, United States

Site Status

University of Michigan Comprehensive Cancer Center SC-2

Ann Arbor, Michigan, United States

Site Status

Mount Sinai School of Medicine Mt. Sinai Medical Center

New York, New York, United States

Site Status

Oregon Health & Sciences University DeptofOregonHealth&Sciences(2)

Portland, Oregon, United States

Site Status

University of Pennsylvania - Clinical Studies Unit Unniv SC

Philadelphia, Pennsylvania, United States

Site Status

Vanderbilt University Medical Center CSOM230G2304

Nashville, Tennessee, United States

Site Status

Swedish Medical Center Swedish

Seattle, Washington, United States

Site Status

Medical College of Wisconsin MCW 2

Milwaukee, Wisconsin, United States

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Novartis Investigative Site

Buenos Aires, , Argentina

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Novartis Investigative Site

Córdoba, , Argentina

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Novartis Investigative Site

Edegem, Antwerpen, Belgium

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Novartis Investigative Site

Jette, Brussels Capital, Belgium

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Novartis Investigative Site

Brussels, , Belgium

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Novartis Investigative Site

Ghent, , Belgium

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Novartis Investigative Site

Leuven, , Belgium

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Novartis Investigative Site

Fortaleza, Ceará, Brazil

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Novartis Investigative Site

Rio de Janeiro, Rio de Janeiro, Brazil

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Novartis Investigative Site

Ribeirão Preto, São Paulo, Brazil

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Novartis Investigative Site

São Paulo, São Paulo, Brazil

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Novartis Investigative Site

Halifax, Nova Scotia, Canada

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Novartis Investigative Site

Montreal, Quebec, Canada

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Novartis Investigative Site

Sherbrooke, Quebec, Canada

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Novartis Investigative Site

Beijing, Beijing Municipality, China

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Novartis Investigative Site

Chengdu, Sichuan, China

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Novartis Investigative Site

Shanghai, , China

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Novartis Investigative Site

Shanghai, , China

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Novartis Investigative Site

Besançon, , France

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Novartis Investigative Site

Caen Cedex9, , France

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Novartis Investigative Site

Le Kremlin-Bicêtre, , France

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Novartis Investigative Site

Lille, , France

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Novartis Investigative Site

Marseille Cédex 5, , France

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Novartis Investigative Site

Pessac, , France

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Erlangen, , Germany

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Novartis Investigative Site

Germering, , Germany

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Novartis Investigative Site

Würzburg, , Germany

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Novartis Investigative Site

Mumbai, Maharashtra, India

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Novartis Investigative Site

Vellore, Tamil Nadu, India

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Novartis Investigative Site

New Delhi, , India

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Petah Tikva, , Israel

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Novartis Investigative Site

Ancona, AN, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Padua, PD, Italy

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Napoli, , Italy

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Novartis Investigative Site

Nagoya, Aichi-ken, Japan

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Novartis Investigative Site

Fukuoka, Fukuoka, Japan

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Novartis Investigative Site

Maebashi, Gunma, Japan

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Novartis Investigative Site

Sapporo, Hokkaido, Japan

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Novartis Investigative Site

Kobe, Hyōgo, Japan

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Novartis Investigative Site

Nankoku, Kochi, Japan

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Novartis Investigative Site

Kyoto, Kyoto, Japan

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Novartis Investigative Site

Suita, Osaka, Japan

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Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Minato-ku, Tokyo, Japan

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Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

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Novartis Investigative Site

Osaka, , Japan

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Novartis Investigative Site

Rotterdam, , Netherlands

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Novartis Investigative Site

Jesus Maria, Lima region, Peru

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Novartis Investigative Site

Miraflores, Lima region, Peru

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Novartis Investigative Site

Gdansk, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Novartis Investigative Site

Moscow, , Russia

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Saint Petersburg, , Russia

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Novartis Investigative Site

Seville, Andalusia, Spain

Site Status

Novartis Investigative Site

Alzira, Valencia, Spain

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Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Bangkok, , Thailand

Site Status

Novartis Investigative Site

Diskapi / Ankara, Ankara, Turkey (Türkiye)

Site Status

Novartis Investigative Site

Istanbul, TUR, Turkey (Türkiye)

Site Status

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Salford, Manchester, United Kingdom

Site Status

Novartis Investigative Site

Norwich, , United Kingdom

Site Status

Novartis Investigative Site

Sheffield, , United Kingdom

Site Status

Novartis Investigative Site

Southampton, , United Kingdom

Site Status

Countries

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United States Argentina Belgium Brazil Canada China France Germany India Israel Italy Japan Netherlands Peru Poland Russia Spain Thailand Turkey (Türkiye) United Kingdom

References

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Lacroix A, Bronstein MD, Schopohl J, Delibasi T, Salvatori R, Li Y, Barkan A, Suzaki N, Tauchmanova L, Ortmann CE, Ravichandran S, Petersenn S, Pivonello R. Long-acting pasireotide improves clinical signs and quality of life in Cushing's disease: results from a phase III study. J Endocrinol Invest. 2020 Nov;43(11):1613-1622. doi: 10.1007/s40618-020-01246-0. Epub 2020 May 8.

Reference Type DERIVED
PMID: 32385851 (View on PubMed)

Newell-Price J, Pivonello R, Tabarin A, Fleseriu M, Witek P, Gadelha MR, Petersenn S, Tauchmanova L, Ravichandran S, Gupta P, Lacroix A, Biller BMK. Use of late-night salivary cortisol to monitor response to medical treatment in Cushing's disease. Eur J Endocrinol. 2020 Feb;182(2):207-217. doi: 10.1530/EJE-19-0695.

Reference Type DERIVED
PMID: 31804965 (View on PubMed)

Fleseriu M, Petersenn S, Biller BMK, Kadioglu P, De Block C, T'Sjoen G, Vantyghem MC, Tauchmanova L, Wojna J, Roughton M, Lacroix A, Newell-Price J. Long-term efficacy and safety of once-monthly pasireotide in Cushing's disease: A Phase III extension study. Clin Endocrinol (Oxf). 2019 Dec;91(6):776-785. doi: 10.1111/cen.14081. Epub 2019 Oct 1.

Reference Type DERIVED
PMID: 31465533 (View on PubMed)

Lacroix A, Gu F, Gallardo W, Pivonello R, Yu Y, Witek P, Boscaro M, Salvatori R, Yamada M, Tauchmanova L, Roughton M, Ravichandran S, Petersenn S, Biller BMK, Newell-Price J; Pasireotide G2304 Study Group. Efficacy and safety of once-monthly pasireotide in Cushing's disease: a 12 month clinical trial. Lancet Diabetes Endocrinol. 2018 Jan;6(1):17-26. doi: 10.1016/S2213-8587(17)30326-1. Epub 2017 Oct 12.

Reference Type DERIVED
PMID: 29032078 (View on PubMed)

Silverstein JM. Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly. Pituitary. 2016 Oct;19(5):536-43. doi: 10.1007/s11102-016-0734-1.

Reference Type DERIVED
PMID: 27405306 (View on PubMed)

Other Identifiers

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2009-011128-70

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSOM230G2304

Identifier Type: -

Identifier Source: org_study_id